FDA.reportPublic FDA data

PMA P850064S049

Device
LifePulse High Frequency Ventilator
Applicant
Bunnell, Inc.
PMA number
P850064
Supplement
S049
Product code
LSZ
Decision date
2023-02-06
Classification
Anesthesiology
Generic name
VENTILATOR, HIGH FREQUENCY
Approval order statement
Notice of Change to the Patient Box Burn-In Fixture used during manufacturing and servicing of the LifePulse High Ventilator, specifically the Patient Box. The Patient Box Burn-In Fixture is used to burn in the Patient Boxes when a ventilator is not being burned-in at the same time.

Current openFDA PMA Record#

Device
LifePulse High Frequency Ventilator
Applicant
Bunnell, Inc.
PMA number
P850064
Supplement
S049
Product code
LSZ
Generic name
VENTILATOR, HIGH FREQUENCY
Decision date
2023-02-06
Decision code
OK30
Date received
2023-01-06
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Notice of Change to the Patient Box Burn-In Fixture used during manufacturing and servicing of the LifePulse High Ventilator, specifically the Patient Box. The Patient Box Burn-In Fixture is used to burn in the Patient Boxes when a ventilator is not being burned-in at the same time.